NCT05477901 Impacts of Cash Transfers on Child Neurodevelopment (Auxilio Brasil)
| NCT ID | NCT05477901 |
| Status | Recruiting |
| Phase | — |
| Sponsor | New York State Psychiatric Institute |
| Condition | Inflammation |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2025-05-28 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 450 participants in total. It began in 2025-05-28 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study examines the impact of Auxilio Brasil (AB), a cash transfer program to mothers of school-age children, on resource-deprived populations in Brazil and its protective effects on child neurodevelopment and mental health. The investigators will conduct a randomized clinical trial (RCT) among those already receiving AB in which 300 families will be randomized in a 1:1 ratio to receive either a high ($40/month) or low ($2/month) supplemental transfer for 2 years. Three hundred children (index child participants; 7-10 years old) will be enrolled across both study arms. Additionally, up to 150 siblings ("sibling participants;" 7-10 years old) will be enrolled. Eligible families who decide to participate will sign a study-specific informed consent (mother) and assent (child) form. The UNIFESP team will conduct the respective assessments at baseline, approximately 8- and 16- months, 24-months and approximately 6-months post-RCT. Aim 1: Determine the impact of high vs low cash transfers on children's exposure to adversities (ACEs) and neurodevelopment. Aim 2: Determine the impact of cash transfers on children's inflammatory markers and HPA activity/cortisol. Exploratory Aim: The investigators will explore (i) whether sex/gender of the children moderates the pathways in the above mediation model; and (ii) whether cash transfer-related effects persist 6 months post-RCT.
Eligibility Criteria
Mother: Inclusion Criteria: 1. Age 23-45 years old 2. Receiving AB cash transfers 3. Has at least two or more children ages 7- 10 years old at time of recruitment (up to 4 children per family) 4. Able to consent Exclusion Criteria: 1\. Mother and child do not reside in same household Child: Inclusion Criterion 1. Age 7-10 years old 2. Intellectual Disability Exclusion Criterion 1. Does not reside in same household as the mother 2. Major Axis I disorder (e.g., Autism, Schizophrenia, Bipolar) 3. Severe Disability 4. MRI contradictions (index child only)
Contact & Investigator
Cristiane Duarte, PhD
PRINCIPAL INVESTIGATOR
New York State Psychiatric Institute
Frequently Asked Questions
Who can join the NCT05477901 clinical trial?
This trial is open to participants of all sexes, aged 23 Years or older, up to 45 Years, studying Inflammation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05477901 currently recruiting?
Yes, NCT05477901 is actively recruiting participants. Contact the research team at cristiane.duarte@nyspi.columbia.edu for enrollment information.
Where is the NCT05477901 trial being conducted?
This trial is being conducted at New York, United States, São Paulo, Brazil.
Who is sponsoring the NCT05477901 clinical trial?
NCT05477901 is sponsored by New York State Psychiatric Institute. The principal investigator is Cristiane Duarte, PhD at New York State Psychiatric Institute. The trial plans to enroll 450 participants.